Agfa submitted mdr report #1225058-2010-00001 to the fda on june 7, 2010 for a site in the us.A 12th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat).This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.Within this 12th occurrence are 812 different study dates from years 2010 to 2014, in which an individual mdr report will be submitted for each associated study date and medical record number (mrn).Currently, 1362 reports contain this incorrect finding information.
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An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality manager.Agfa's investigation into this occurrence of rmat customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: original measurement label was "low muscular three pk vel" - this was changed to "asd pk vel".Potential impact: if the change was made after reports had been generated with the original sentence selected, those reports prior to the change could display incorrect clinical data if viewed in rm or if used as a template for a repeat study on that pt - in this example the two disease states are very different, leading to potential incorrect diagnosis.On 11/14/2014: also, if the measurement (id/hlcode) is used to populate a findings sentence in the system, all reports made after the edit with the finding and measurement selected will also be affected.As stated above, if the change was made after reports had been generated with the original sentence of "low muscular three pk vel" the measurement label would not read as the reading physician intended, but rather would be changed to "asd pk vel".There has been no reported pt harm for this occurrence.A reportable correction is underway for this issue and has been reported to the fda via reference #z-2112-10.Agfa will follow the rmat post market verification work instructions to correct the sentence finding.Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.Please reference report number 1225058-2014-06015 for specific study date/s and medical record number/s.
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